Stellate Ganglion Block in Control of Arrhythmia in Laparoscopic Cholecystectomy

NCT04837495 | Completed DMC

• 1 other identifier: IRB17101436
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

During Laparoscopic cholecystectomy, carbon dioxide (CO2) pneumoperitoneal laparoscopic surgery, CO2-pneumoperitoneum activates the sympathoadrenomedullary system to increase the release of catecholamines such as epinephrine (E) norepinephrine (NE) and dopamine (DA). During stress, E and NE are secreted by the adrenal medulla into blood circulation to promote glycogenolysis to increase blood glucose, speed up lipolysis and accelerate heartbeats. Stellate g anglion block (SGB) reters to the blockade of sympathetic nerves including the large area covered by middle cervical, vertebral arterial. stellate ganglions and ther pre- and post- ganglions. SGB affects both peripheral and central nervous systems. In the peripheral system. the sympathetic pre- and post-ganglionic fibers in the innervated areas of stellate ganglion are affected. Therefore, the control of vascular dilatation and constriction, muscular movement, bronchial smooth muscle relaxation and contraction, and pain conduction, by sympathetic nerves is inhibited. In the central nervous system, the hypothalamus is mainly involved in the regulation of systemic autonomic nervous, immune and endocrine systems, and to maintain homeostasis. CO2-pneumoperitoneum causes severe stress-related homeostatic disorders including arrhythmia and blood pressure changes. This study will examine the effects of stellate ganglion block (SGB) on hemodynamics and stress response in patients undergoing CO-pneumoperitoneal surgery.

Conditions

Arrythmia; Pain, Acute

Keywords

Arrythmia; Acute pain

Outcome Measures

Primary Outcomes (1)

• Arrhythmia

  the incidnese of Arrhythmia

  introperative period

Secondary Outcomes (1)

• Postoperative pain

  24 hours postoperatively

Study Arms (2)

Stellate Ganglion block group

ACTIVE COMPARATOR

will include 20 patients: each one will receive 10 ml lidocaine 2% right stellate ganglion block (RSGB) under sonar guidance

Procedure: right stellate ganglion block

Control group

NO INTERVENTION

will include 20 patients: a control group

Interventions

right stellate ganglion block PROCEDURE

The skin should be anaesthetised with lidocaine 2%. Using a lateral approach and in-plane imaging, a blunt regional anaesthesia needle should be advanced deep to the carotid sheath towards the longus colli muscle. Following careful aspiration, inject 10 ml lidocaine 2% that will result in expansion of the fascia of the longus colli. Confirmation of the SGB success can be detected by warming of left upper limb and left Horner's syndrome.

Stellate Ganglion block group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 -60 years
• american society of anesthesiologists status I-II
• Scheduled for elective laparoscopic cholecystectomy

You may not qualify if:

• Patients with chronic renal dysfunction.
• Patients with hypo/hyper-thyroidism.
• Patients with diseases of the autonomic and central nervous systems.
• Patients with cardiopulmonary dysfunction.
• Patients with history of treatment with long-term oral tranquilizers.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Acute Pain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 30, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 31, 2022
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

EG (1)